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Study of Stereotactic Body Radiotherapy with or without Darolutamide for Patients with Oligorecurrent Prostate Cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as oligorecurrent prostate cancer. This type of cancer occurs when prostate cancer returns in a limited number of areas after initial treatment. The study is investigating the effects of a treatment called stereotactic body radiotherapy (SBRT), which is a precise form of radiation therapy, with or without the addition of a medication named darolutamide, also known by its code name BAY 1841788. Darolutamide is a chemical substance used to help manage prostate cancer.

The purpose of this study is to compare the outcomes of patients receiving SBRT alone to those receiving SBRT combined with darolutamide. Participants in the study will be randomly assigned to one of these two treatment groups. The study will monitor the participants over a period to see how well the cancer is controlled and to observe any side effects. The main focus is on how long patients remain free from cancer spreading to other parts of the body.

Throughout the study, researchers will also look at other important factors such as the time until the next treatment is needed, overall survival rates, and the quality of life of the participants. The study aims to provide valuable information on whether adding darolutamide to SBRT offers better outcomes for patients with oligorecurrent prostate cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have a confirmed diagnosis of prostate cancer and meet specific eligibility criteria, such as being asymptomatic for metastatic prostate cancer and having a maximum of 5 metastases.
The patient must provide written informed consent in accordance with international and local regulations.
Step 2
Randomization
The patient will be randomly assigned to one of two groups: one receiving stereotactic body radiotherapy (SBRT) alone, and the other receiving SBRT combined with darolutamide.
Step 3
Treatment phase
For patients in the SBRT plus darolutamide group, darolutamide will be administered orally in the form of film-coated tablets. The specific dosage and frequency will be determined by the study protocol.
SBRT will be administered to treat all detected lesions, with the total number of lesions not exceeding five.
Step 4
Monitoring and follow-up
Throughout the trial, the patient's health and response to treatment will be monitored regularly. This includes assessing metastasis-free survival, clinical progression-free survival, and other health outcomes.
The trial aims to evaluate the effectiveness of the treatment in preventing the spread of cancer and improving survival rates.
Step 5
Completion of the trial
The trial is expected to conclude by February 12, 2026. Upon completion, the patient's overall health and quality of life will be assessed to determine the long-term effects of the treatment.

Who can join the trial?

10 criteria

Must have a confirmed initial diagnosis of **adenocarcinoma of the prostate**, which is a type of prostate cancer.
Must provide written informed consent before joining the study, following international and local rules.
Must have a **biochemical relapse** of prostate cancer after initial prostate treatment, which means the cancer has returned as shown by specific blood tests.
If the patient had surgery to remove the prostate (radical prostatectomy) and the cancer has returned, they can join even if they haven't had additional prostate bed radiotherapy. However, if they haven't had this radiotherapy and have certain conditions, it is required.
If the patient didn't have surgery but had radiotherapy and the cancer is suspected to have returned, a biopsy must confirm this. If confirmed and there are also metastases, they must undergo additional local treatment.
Must have a **metastatic relapse** detected on a special scan called **PSMA PET-CT**, with no more than 5 cancer spots. If there is also **N1 disease**, which means cancer in nearby lymph nodes, all spots must be treated, and the total number of spots must not exceed 5.
Must not have symptoms from metastatic prostate cancer.
Must be 18 years or older.
Must have a **WHO class 0-1**, which means they are fully active or have some symptoms but can still do light work.
Must not have any psychological, family, social, or location issues that could prevent them from following the study rules and schedule. These should be discussed before joining the study.

Who cannot join the trial?

4 criteria

Only men can participate in this study. Women are not eligible.
Participants must be within a specific age range, typically adults and older adults.
Individuals with certain medical conditions other than **oligorecurrent prostate cancer** may not be eligible.
Participants should not belong to a vulnerable population, which means they should not be in a situation where they are unable to protect their own interests.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Az St-Jan Brugge-Oostende A.V.
Verified
Brugge, Belgium
Gasthuiszusters Antwerpen
Verified
Antwerp, Belgium
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

Darolutamide
is a medication used in this trial to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, it is being tested to see if it can improve outcomes when combined with stereotactic body radiotherapy (SBRT) for patients with a specific type of recurrent prostate cancer.
Stereotactic Body Radiotherapy (SBRT)
is a type of radiation therapy that delivers high doses of radiation to a targeted area of the body. It is used in this trial to treat prostate cancer that has returned in a limited number of locations. The goal is to destroy cancer cells while minimizing damage to surrounding healthy tissue.

Darolutamide

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating oligo-recurrent prostate cancer. The main therapeutic indication for darolutamide is prostate cancer, specifically in cases where the cancer has returned in a limited number of sites. At the molecular level, darolutamide works by blocking the action of male hormones, such as testosterone, which can promote the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor, which helps to slow down or stop the growth of cancer cells.

Investigated diseases

Oligorecurrent Prostate Cancer – This condition refers to a state where prostate cancer has returned after initial treatment but is limited to a few sites, typically fewer than five. It is characterized by the recurrence of cancerous cells in the prostate region or nearby areas, often detected through imaging or rising prostate-specific antigen (PSA) levels. The progression of oligo-recurrent prostate cancer can vary, with some cases remaining stable for extended periods, while others may spread to additional sites. The disease is often managed with targeted therapies aimed at controlling the limited number of metastases. Understanding the behavior of oligo-recurrent prostate cancer is crucial for determining appropriate management strategies.